Recall Z-0071-2017 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures
| Date | Oct 11, 2016 (initiated Sep 23, 2016) |
| Status | Terminated |
| Reason | GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated September 23, 2016 to customers. The letter informed customers of the affected product, safety issue, and safety instructions for immediate mitigation of the issue. GE Healthcare will correct all affected products at no cost to customers. A GE Healthcare representative will the customers to arrange for the correction. Please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 148 total |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME Ge Healthcare Surgery GE Oec Medical Systems, Inc., May 17, 2013 |